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Guaifenesin

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Active ingredient
Guaifenesin 100 mg/5 mL
Other brand names
Drug class
Expectorant
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
October 21, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 100 mg/5 mL
Other brand names
Drug class
Expectorant
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
October 21, 2025
Manufacturer
Method Pharmaceuticals, LLC
Registration number
M012
NDC root
58657-509
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Guaifenesin is a liquid expectorant that comes in a concentration of 100 mg per 5 mL. It is commonly used to help loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive. This means that if you are dealing with congestion or a cough, guaifenesin can assist your body in clearing out mucus, helping you breathe easier.

Uses

If you're dealing with a cough that produces mucus, this medication can help. It works by loosening phlegm (a thick substance produced in your lungs) and thinning out bronchial secretions. This makes it easier for you to cough up the mucus, leading to a more productive cough.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication. Additionally, there are no nonteratogenic effects reported. This makes it a safe option for those who need relief from their cough without worrying about these specific risks.

Dosage and Administration

When using this medication, it's important to follow the correct dosage to ensure safety and effectiveness. For adults and children aged 12 years and older, you should take 2 to 4 teaspoonfuls every 4 hours, but remember not to exceed 6 doses in a 24-hour period. If your child is between 6 and 12 years old, the recommended dose is 1 to 2 teaspoonfuls every 4 hours.

For younger children aged 2 to under 6 years, you can give them ½ to 1 teaspoonful every 4 hours. However, if your child is under 2 years old, it's best to consult a doctor before administering the medication. Always keep track of how many doses you've given to avoid taking too much.

What to Avoid

If you are using this medication, it's important to know when to stop. You should stop using it and consult your doctor if your cough lasts more than 7 days, returns after improvement, or is accompanied by symptoms like fever, rash, or a persistent headache. These could indicate a more serious health issue that needs attention.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. However, always prioritize your health and seek medical advice if you have any concerns.

Side Effects

If you experience a cough that lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, it's important to stop using the medication and consult a doctor, as these symptoms may indicate a serious condition. Additionally, you should speak with a healthcare professional before using this medication if your cough is associated with excessive mucus or if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have a cough that produces a lot of mucus or if your cough is chronic, which can happen with conditions like smoking, asthma, chronic bronchitis, or emphysema.

You should stop using the medication and contact your doctor if your cough lasts more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a more serious health issue.

Always keep this medication out of reach of children. If an overdose occurs, seek medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than typical side effects.

Always err on the side of caution—if you notice anything concerning, don’t hesitate to reach out for professional assistance. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you have a child under 2 years old, it's important to consult with a doctor before using this medication. For children aged 2 to under 6 years, the recommended dosage is ½ to 1 teaspoonful every 4 hours. If your child is between 6 and 12 years old, they can take 1 to 2 teaspoonfuls every 4 hours.

For anyone aged 12 and older, including adults, the dosage increases to 2 to 4 teaspoonfuls every 4 hours. Remember, regardless of age, no one should take more than 6 doses in a 24-hour period to ensure safety.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best quality and safety of your product, store it at a temperature between 20°-25°C (68°-77°F). This temperature range helps maintain its effectiveness. When you receive the product, you'll notice it comes with a tamper-evident seal under the cap, which is an important safety feature. This seal indicates that the product has not been opened or altered, so be sure to check it before use.

Handle the product carefully to avoid any damage. Always ensure that the storage area is clean and free from contaminants to maintain a sterile environment. If you have any questions about disposal or further handling instructions, please refer to the guidelines provided with your product.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Always keep this medication out of reach of children. In the event of an overdose, seek medical help or contact a Poison Control Center immediately.

FAQ

What is Guaifenesin?

Guaifenesin is a liquid expectorant that helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

What are the recommended dosages for Guaifenesin?

For adults and children 12 years and over, the dosage is 2 to 4 teaspoonfuls every 4 hours. For children 6 to under 12 years, it's 1 to 2 teaspoonfuls every 4 hours, and for children 2 to under 6 years, it's ½ to 1 teaspoonful every 4 hours.

Are there any contraindications for Guaifenesin?

No contraindications are specified in the provided information.

What should I do if my cough lasts more than 7 days?

You should stop using Guaifenesin and ask a doctor if your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

Can I use Guaifenesin if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Guaifenesin.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

How should Guaifenesin be stored?

Guaifenesin should be stored at 20°-25°C (68°-77°F) and is packaged with a tamper evident seal under the cap.

Packaging Info

Below are the non-prescription pack sizes of Guaifenesin. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin.
Details

Drug Information (PDF)

This file contains official product information for Guaifenesin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients by loosening phlegm and thinning bronchial secretions, thereby enhancing the productivity of coughs.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 to 4 teaspoonfuls every 4 hours, not exceeding 6 doses within a 24-hour period. For children aged 6 years to under 12 years, the recommended dosage is 1 to 2 teaspoonfuls every 4 hours, also adhering to the maximum limit of 6 doses in a 24-hour period.

For children aged 2 years to under 6 years, the dosage is ½ to 1 teaspoonful every 4 hours, with the same restriction on the total number of doses. It is important to consult a physician for children under 2 years of age regarding appropriate dosing.

Contraindications

Use is contraindicated in patients who experience a cough lasting more than 7 days, a recurrent cough, or a cough accompanied by fever, rash, or persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Warnings and Precautions

Healthcare professionals are advised to exercise caution when recommending this product. Prior to use, patients should be instructed to consult a physician if they experience a cough that is associated with excessive phlegm (mucus) or if they have a chronic cough, particularly in cases related to smoking, asthma, chronic bronchitis, or emphysema.

Patients should be advised to discontinue use and seek medical attention if their cough persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires further evaluation.

It is imperative to keep this product out of the reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended to ensure appropriate management.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may necessitate immediate medical attention. Patients are advised to stop use and consult a healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms could indicate a serious underlying condition.

Additionally, patients should seek medical advice prior to using this medication if they have a cough that occurs with excessive phlegm (mucus) or if they have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. These conditions may require a different therapeutic approach or further evaluation by a healthcare provider.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Guaifenesin. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 years to under 6 years, the recommended dosage is ½ to 1 teaspoonful every 4 hours. In children aged 6 years to under 12 years, the dosage increases to 1 to 2 teaspoonfuls every 4 hours. For adolescents and adults aged 12 years and over, the dosage is 2 to 4 teaspoonfuls every 4 hours. It is important to note that no more than 6 doses should be taken in any 24-hour period.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt action is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. This may include monitoring vital signs, providing respiratory support, and administering specific antidotes if applicable. The healthcare provider should follow established protocols and guidelines for the management of overdose cases to ensure optimal patient outcomes.

It is essential to maintain open communication with the Poison Control Center for guidance on the most effective treatment strategies based on the substance involved and the clinical presentation of the patient.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important for patients to be aware of the signs that warrant discontinuation of use; they should stop taking the medication and consult a healthcare provider if their cough persists for more than 7 days, returns after improvement, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Patients should also be encouraged to consult with their healthcare provider prior to use if they are experiencing a cough that is associated with excessive phlegm (mucus). Additionally, it is advisable for patients to seek medical advice before using the medication if they have a cough that is chronic or lasts for an extended period, particularly in cases related to smoking, asthma, chronic bronchitis, or emphysema.

Storage and Handling

The product is supplied with a tamper-evident seal under the cap, ensuring the integrity of the packaging. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F) to maintain its efficacy and safety. Proper storage conditions are essential to preserve the quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is also important to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Guaifenesin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Guaifenesin, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.